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Investing in Ex Ante Regulation: Evidence from Pharmaceutical Patent Examination

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  • Michael D. Frakes
  • Melissa F. Wasserman

Abstract

We explore how the Patent Office may improve the quality of issued patents on “secondary” drug features by giving examiners more time to review drug-patent applications. Our findings suggest that current time allocations are causing examiners to issue low quality secondary patents on the margin. To assess the merits of expanding ex ante scrutiny of drug-patent applications at the agency, we set forth estimates of the various gains and losses associated with giving examiners more time, including reduced downstream litigation costs and added personnel expenses, along with both the static gains and dynamic innovation losses associated with earlier generic entry.

Suggested Citation

  • Michael D. Frakes & Melissa F. Wasserman, 2020. "Investing in Ex Ante Regulation: Evidence from Pharmaceutical Patent Examination," NBER Working Papers 27579, National Bureau of Economic Research, Inc.
  • Handle: RePEc:nbr:nberwo:27579
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    More about this item

    JEL classification:

    • I18 - Health, Education, and Welfare - - Health - - - Government Policy; Regulation; Public Health
    • O34 - Economic Development, Innovation, Technological Change, and Growth - - Innovation; Research and Development; Technological Change; Intellectual Property Rights - - - Intellectual Property and Intellectual Capital

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